Live blogging: FDA advisory review of Arena's diet pill

Arena Pharmaceuticals is hoping for a favorable review on Thursday from a Food and Drug Administration advisory panel on lorcaserin, the San Diego company's experimental weight loss drug.
— Provided by Arena Pharmaceuticals

Arena Pharmaceuticals is hoping for a favorable review on Thursday from a Food and Drug Administration advisory panel on lorcaserin, the San Diego company's experimental weight loss drug.
/ Provided by Arena Pharmaceuticals

Click here to view the live chat 9:04 a.m.: The committee is taking a lunch break. The meeting will continue in an hour. I'll be back here blogging the rest of the session. 8:56 a.m.: One committee member called the drug's weight-loss effectiveness "very modest" while pointing out that Arena's clinical trials of lorcserin didn't look closely at the safety of the drug in people with diabetes and heart problems, who are among the those most likely to take the drug. 8:52 a.m.: Now, the FDA staffers are taking questions from committee members. 8:43 a.m.: The FDA staff concludes its presentation on the lorcaserin by offering a benefit/risk analysis of the drug. On the plus side, the treatment offers "clinically meaningful" weight loss for some patients, however the results aren't any better than those offered by existing prescription diet drugs. On the negative side, lorcaserin was associated with a slightly higher risk of depression and three times more cognitive adverse events when compared to results from the placebo group, and the drug was associated with cancerous tumor development in rats. 8:30 a.m.: Slightly more patients on lorcaserin had suicidal thoughts than those on a placebo, the FDA staffer said. Only one person - a 36-year-old woman - attempted suicide while taking the drug as part of the clinical trials. The woman, who took an overdose of other medications, had recently been fired from her job after being accused of embezzling funds, the staffer said. 8:19 a.m.: To the commentor: The live webcast of the committee meeting is available on a subscription basis ($140) from the FDA at FDAAC.com Sorry for the late response to your question. I just saw it a minute ago. 8:15 a.m.: All of the staff's analysis of lorcaserin was detailed in a lengthy briefing document made public on Tuesday, so none of this information is new this morning. What's yet to be seen, and most important, is whether any of the committee members will have the same kinds of concerns about safety and efficacy being expressed by the staff. 8:10 a.m.: Those losing at least 5 percent of body weight while taking the drug were only 3 percent greater than those taking the placebo, below the 5-percent threshold required by the FDA, an agency staffer said. Additionally, the drug just barely met the agency's minimal requirement for average weight loss, she said. 7:51 a.m.: The conclusion by Arena researchers that breast cancer in rats receiving lorcaserin was driven by mechanisms unrelated to the drug aren't supported by the clinical trial data, Alavi said. "It is our view that the relevance of mammary tumors in rodents cannot be dismissed" when considering cancer risks in humans taking the drug, he said. 7:45 a.m.: FDA staffers are now going over their review of the clinical trial data related to the occurrence of cancers in animals given lorcaserin. Dr. Fred Alavi said higher rates of malignant tumors occurred in female rates that received the drug in doses more than seven times larger than those given to humans. In male rats, higher tumor rates surfaced in does more than 17-times higher than those given to humans. Mammory tumors occurred in both male and female rats, Alavi said. 7:25 a.m. : We're back in session. 7:05 a.m.: The committee has taking a 15 minute break. 6:55 a.m.: Committee member Dr. Michael Proschan reiterated his disagreement with the methodology used for one particular analysis of valvulopathy risk, but he conceded that other data analysis "show that (the risk of valvulopathy) is within the right range." "There's not evidence of terrible harm in valvulopathy," he said. 6:50 a.m.: Several committee members have questioned the conclusion by Arena researchers that the incidence of new heart valve problems was no higher among patients taking lorcaserin than those receiving a placebo. Specifically, the members criticized the statistical analysis of the clinical trial data. "You can say it almost achieved non-inferiority, but almost only counts in horseshoes and hand grenades," one committee member said. Dr. Gary Cook, the company's biostatistics expert from the University of North Carolina, is now defending the data analysis. 6:36 a.m.: Following brief comments in support of drug approval from Dr. Stephen Smith, an obesity researcher who headed the clinical trials of lorcaserin, Arena completed its presentation. Committee members are now posing questions to the Arena representatives. 6:28 a.m.: Arena plans to continue studying the safety of lorcaserin after it's introduced into the market, Anderson said. That work will include the creation of a registry to monitor women who become pregnant while on the drug and separate studies of type II diabetes patients and children taking the treatment, she said. 6:25 a.m.: Lorcaserin didn't affect mental abilities or increase suicidal thoughts among patients taking the drug, but abnormal dreams and nightmares were more common among a "very small number" of them, Anderson. 6:18 a.m.: After two years of clinical trials, 2.6 percent of patients taking lorcaserin tested positive for heart valve problems, about the same as the 2.7 percent who were taking placebos, Anderson said. Over that two year period, the rate of valvulopathy among people in both groups declined, she said. "This information adds to the body of evidence that lorcaserin is not associated with valvulopathy," Anderson said. 6:10 a.m.: Turning to cancer, researchers found no increased occurence of malignant tumors in patients who received lorcaserin, Anderson said. 6:06 a.m.: Few side effects were noted among patients taking lorcaserin in the first year of clinical trials and they occurred a extremely low rates, Anderson said. Headaches were the only problem that was more than 5 percent more frequent among those taking the drug when compared to people on a placebo, she said. 6:02 a.m.: Dr. Christy Anderson, vice president of clinical development for Arena , is now reviewing the safety data from clinical trials of lorcaserin. 5:58 a.m.: After two years, about 68 percent of patients taking lorcaserin maintained a weight loss of at least 5 percent, Shanahan said. That same threshold was achieved by only 50 percent of those who had taken the drug for the first year but switched to a placebo for the second year. 5:53 a.m.: About 22 percent of patients receiving lorcaserin lost at least 10 percent of their body weight, more than double the rate found among people receiving a placebo, Shanahan said. 5:50 a.m.: Shanahan is now reviewing the efficacy details of the clinical trials conducted on lorcaserin. More than 8,000 people participated in 18 studies of the drug, he said. All of them, including those who received a placebo, were asked to exercise at 30 minutes a day and received regular sessions with a life-style counselor. 5:40 a.m.: Dr. Williams said that breast, thyroid and liver tumors that surfaced in rats receiving high doses of lorcaserin were triggered by biological mechanisms that "are not relevant to humans." 5:28 a.m.: Dr. Gary Williams, a cancer expert testifying for Arena, noted that cancerous tumors found in test rats developed after the animals received high doses lorcaserin that far exceeded the standards for studying the cancer risk of new medications. They also were types of tumors that normally occur in rats, he said. In human studies using therapeutic doses, no higher rates of cancer were documented. "My conclusion is that lorcaserin does not cause a cancer risk to humans at the recommended therapeutic dose," he told the panel. 5:22 a.m.: In early tests of the drug on rats, Arena researchers found lower food intake and weight loss without any affect on the heart valves of the animals, Shanahan said. Federal drug regulators are particularly sensitive to heart valve issues associated with weight loss pills because of the trouble with fen-phen, a popular weight-loss drug cocktail that was pulled from the U.S. market in 1997. 5:16 a.m.: Dr. William Shanahan, Arena's chief medical officer, has begun the company's presentation on lorcaserin. He noted that the company has worked on six compounds since its founding in 1997, with lorcaserin being the most advanced in the development process. 5 a.m.: Good morning. The hearing is underway at a hotel conference room on the campus of the University of Maryland University College in Adelphi, Md. I'm monitoring the action in San Diego at the Union-Tribune's main office through a live webcast of the meeting. The 20 members of the committee have just introduced themselves, and they include physicians from the Mayo Clinic, Johns Hopkins and other universities; the federal Centers for Disease Control and Prevention; and representatives of consumers and the pharmaceutical industry.